CELESTONE CHRONODOSE

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE

متاح من:

ORGANON PHARMA ISRAEL LTD., ISRAEL

ATC رمز:

H02AB01

الشكل الصيدلاني:

SUSPENSION FOR INJECTION

تركيب:

BETAMETHASONE ACETATE 3 MG/ML; BETAMETHASONE SODIUM PHOSPHATE 3.945 MG/ML

طريقة التعاطي:

I.M, INTRA-ARTICULAR, INTRA-LESIONAL

نوع الوصفة الطبية :

Required

المصنعة من قبل:

ORGANON LLC, USA

المجموعة العلاجية:

BETAMETHASONE

المجال العلاجي:

BETAMETHASONE

الخصائص العلاجية:

Indicated in the management of conditions known to be responsive to corticosteroid therapy.

تاريخ الترخيص:

2015-02-28

نشرة المعلومات

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine can be sold with a doctor’s prescription only
CELESTONE
CHRONODOSE
SUSPENSION FOR INJECTION
Each ampule contains
:
3 mg betamethasone as betamethasone sodium phosphate
3 mg betamethasone acetate.
Inactive ingredients and allergens: see section 2 ”Important
information about some of
ingredients of this medication” and section 6 “Additional
information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet contains
concise information about this medicine. If you have any further
questions, consult your doctor
or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may harm
them, even if it seems to you that their illness similar to yours.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
Celestone Chronodose is indicated in the management of conditions
known to be responsive to
corticosteroid therapy
THERAPEUTIC GROUP: corticosteroids for systemic use, glucocorticoid.
Celestone Chronodose, suspension for injection (betamethasone) belongs
to a group of
medicines known as corticosteroids. These cortisone-type drugs help
relieve parts of the body
with an inflammation. They reduce swelling, redness, itching and
allergic reactions, and are
often part of the treatment of a number of diseases.
2. BEFORE USING THIS MEDICINE
DO NOT USE CELESTONE CHRONODOSE IF:
-
you are allergic to the active substances or any of the other
ingredients of this
medicine (listed in section 6).
-
you are allergic to corticosteroids.
-
you are suffering from infections caused by fungi or yeasts
.
SPECIAL WARNINGS REGARDING THE USE OF CELESTONE CHRONODOSE
Before using Celestone Chronodose, tell your doctor if you have:
-
diabetes;
-
a viral or bacterial infection;
-
muscle weakness;
-
thyroid problems;
-
liver problems;
-
eye problems;
-
seizures;
-
stomach or intestinal problems;
-
kidney problems;
-
heart or blood pressure problems;
-
pheochromocytoma (a tumour of the

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Celestone Chronodose
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 3 mg betamethasone as betamethasone sodium phosphate
and 3 mg
betamethasone acetate.
Excipients with known effect:
1 ml ampoule contains 0.2 mg benzalkonium chloride which is equivalent
to 0.2 mg/ml.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection for intramuscular, intra-articular,
intralesional, administration and
injection in soft tissue.
Clear, colorless liquid containing easily re-suspendable white
particles.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
The product is indicated in the management of conditions known to be
responsive to
corticosteroid therapy.
When oral therapy is not feasible and the strength, dosage form, and
route of administration
of the drug reasonably lend the preparation to the treatment of the
condition, Celestone
Chronodose suspension for intramuscular use is indicated as follows:
Endocrine disorders: Primary or secondary adrenocortical insufficiency
(hydrocortisone or
cortisone is the drug of choice; synthetic analogs may be used in
conjunction with
mineralocorticoids where applicable; in infancy, mineralocorticoid
supplementation is of
particular importance).
Acute adrenocortical insufficiency (hydrocortisone or cortisone is the
drug of choice;
mineralocorticoid supplementation may be necessary, particularly when
synthetic analogs
are used). Preoperatively and in the event of serious trauma or
illness, in patients with known
adrenal insufficiency or when adrenocortical reserve is doubtful.
Shock unresponsive to conventional therapy if adrenocortical
insufficiency exists or is
suspected. Congenital adrenal hyperplasia. Nonsuppurative thyroiditis.
Hypercalcemia
associated with cancer.
_RHEUMATIC DISORDERS_: As adjunctive therapy for short term
administration (to tide the patient
over an acute episode or exacerbation) in post-traumatic
osteoarthritis; synovitis of
osteoarthritis; rh